An investigational¹ malaria² vaccine³ has been found to be safe, to generate an immune system response, and to offer protection against malaria infection in healthy adults, according to the results of an early-stage clinical trial published Aug. 8 in the journal Science. The vaccine, known as PfSPZ Vaccine, was developed by scientists at Sanaria Inc., of Rockville, Md. The clinical evaluation⁴ was conducted by researchers at the National Institute of Allergy⁵ and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators at the Walter Reed Army Institute of Research and the Naval⁶ Medical Research Center, both in Silver Spring, Md.

 

Malaria is transmitted to humans by the bite of an infected mosquito. After the bite occurs, infectious malaria parasites⁷ in the immature⁸, sporozoite（孢子体） stage of their life cycle first travel to the liver, where they multiply, and then spread through the bloodstream, at which time symptoms develop.

 

The PfSPZ Vaccine is composed of live but weakened sporozoites of the species Plasmodium falciparum, the most deadly of the malaria-causing parasites.

 

"The global burden of malaria is extraordinary and unacceptable," said NIAID Director Anthony S. Fauci, M.D. "Scientists and health care providers have made significant gains in characterizing, treating and preventing malaria; however, a vaccine has remained an elusive⁹（难懂的，易忘的） goal. We are encouraged by this important step forward."

 

The Phase I trial, which took place at the NIH Clinical Center in Bethesda, received informed consent from and enrolled¹⁰ 57 healthy adult volunteers ages 18 to 45 years who never had malaria. Of these, 40 participants received the vaccine and 17 did not. To evaluate the vaccine's safety, vaccinees were split into groups receiving two to six intravenous doses of PfSPZ Vaccine at increasing dosages. After vaccination¹¹, participants were monitored closely for seven days. No severe adverse¹² effects associated with the vaccine occurred, and no malaria infections related to vaccination were observed.

 

Based on blood measurements, researchers found that participants who received a higher total dosage of PfSPZ Vaccine generated more antibodies against malaria and more T cells -- a type of immune system cell -- specific to the vaccine.

 

To evaluate whether and how well the PfSPZ Vaccine prevented malaria infection, each participant -- the vaccinees as well as the control group that did not receive vaccine -- was exposed to bites by five mosquitoes carrying the P. falciparum strain from which the PfSPZ Vaccine was derived¹³. This controlled human malaria infection procedure -- a standard process in malaria vaccine trials -- took place three weeks after participants received their final vaccination. Participants were monitored as outpatients for seven days and then admitted to the NIH Clinical Center, where they stayed until they were diagnosed with malaria, treated with anti-malarial drugs and cured of infection, or shown to be free of infection.

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